New Impurity Found in Blood Pressure Drug Prompts Expanded FDA Recall

Regulatory NewsRegulatory News | 04 March 2019 |  By 

The US Food and Drug Administration (FDA) on Friday announced that Indian drugmaker Hetero Labs is recalling 87 lots of losartan tablets distributed by Camber Pharmaceuticals after testing found the drugs contained a potentially carcinogenic impurity, N-Nitroso-N-methyl-4 aminobutyric acid (NMBA).
The recall is the latest in a series of recalls tied to the discovery of nitrosamine impurities in angiotensin II receptor blocker (ARB) drugs in the last year.
Previously, the discovery of N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) impurities prompted recalls of ARB drugs containing active pharmaceutical ingredients (APIs) manufactured by Hetero, Mylan Pharmaceuticals and Zhejiang Huahai Pharmaceuticals.
So far, FDA says that NMBA has only been detected in tablets using APIs made by Hetero Labs. Another Indian drugmaker, Torrent Pharmaceuticals, has expanded its recall of losartan products to include an additional 114 lots as they were made using APIs from Hetero that contained NMBA.
“We are deeply concerned about the presence of a third nitrosamine impurity in certain ARB medications, but it’s important to underscore that, based on the FDA’s initial evaluation, the increased risk of cancer to patients with NMBA exposure appears to be the same for NDMA exposure but less than the risk from NDEA exposure,” said FDA Commissioner Scott Gottlieb.
In response to the finding of NMBA in Hetero APIs, FDA last week updated its interim list of acceptable intake of nitrosamine impurities in ARB products to include limits for NMDA at 96 nanograms per day. At that level, FDA says the impurity poses a 1:100,000 risk for developing cancer after 70 years of exposure at the daily acceptable limit.
FDA says it will continue its effort to identify the root cause(s) of the impurities and is working to develop new test methods for identifying NMBA and other impurities in ARB products.


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